Efficacy of Iodine Complex Against COVID-19 Patients

Phase 1

• Conditions: Covid19; SARS-CoV-2; Corona Virus Infection
• Interventions: Drug: Iodine Complex; Drug: Placebo; Drug: Idoine Complex

• Registration Number: NCT04473261
• Lead Sponsor: Sohaib Ashraf

Brief Summary

The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

Detailed Description

The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.

Study Timeline

• Study Start: 2020-07-14
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-16
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-04
• Last Update Posted: 2021-07-07
• Primary Completion: 2021-08-15
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Positive PCR with mild to moderate disease

Exclusion Criteria

• Allergic to iodine
• Any co-morbidity other than hypertension and dietetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodine Complex (Capsule form)	Iodine Complex	Iodine Complex) capsule (200mg) will be given three times a day
Standard Care Alone	Placebo	Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting.
Iodine Complex (Nasal Spray)	Idoine Complex	Iodine complex throat spray of 2 puffs three times a day.
Iodine Complex (Syrup form)	Iodine Complex	Iodine Complex syrup form (40ml) will be given three times a day

Primary Outcome Measures

Name	Time	Method
HRCT chest	14 days	Time taken for radiological improvement
qRT-PCR	14 days	Time taken for viral load clearance

Secondary Outcome Measures

Name	Time	Method
Severity of Symptoms	14 days	Time taken for symptomatic response in patients

Trial Locations

Locations (1)

Shaikh Zayed Hospital; 🇵🇰 Lahore, Pakistan